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Vectura Group Plc Report and Accounts for the Nine-Month Period

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Vectura Group Plc Report and Accounts for the Nine-Month Period Vectura Group plc R eport and Accounts for the nine-month period ended 31 December 2016 TRANSFORMING THE LIVES OF AIRWAYS DISEASE PATIENTS Vectura Group plc Report and Accounts for the nine-month period ended 31 December 2016 VECTURA IS AN INDUSTRY-LEADING INHALED AIRWAYS DISEASE FOCUSED BUSINESS WITH PROPRIETARY FORMULATIONS AND DEVICES OPERATIONAL HIGHLIGHTS Significant progression for partnered and wholly-owned assets NOVEL PATENTED MOLECULE AND DEVICE PARTNERING flutiform® supply chain volumes at record levels CY2016 VR465 (Global)(1) flutiform® is an inhaled fixed-dose combination of an anti-inflammatory (ICS) and a Vectura’s adapted FOX® handheld smart nebuliser device used to deliver Ablynx’s bronchodilator (LABA) in a pMDI device inhaled nanobody for RSV in infants • Ablynx exercised licence option triggering a €1.5m milestone • Phase IIb study initiated Ultibro® Breezhaler® (EU and ROW) net sales grew 37%, benefiting from FLAME data Ultibro® Breezhaler® is a first-in-class once-daily fixed dose inhaled dual bronchodilator VR942 (Global) (LAMA/LABA) in a DPI device Inhaled dry powder biologic for uncontrolled asthma in co-development with UCB • Phase I study completed • Phase II trial to start in H2 2017 VR876 (EU and ROW, ex-US) Vectura’s adapted FOX® handheld smart nebuliser device (branded as BreelibTM) • First EU regulatory progress enabling commercialisation VR2076 (Global) • Launch in Poland post-period in April 2017 An inhaled fixed-dose dual bronchodilator (LAMA/LABA) and anti-inflammatory (ICS) in a pMDI device • Second licensing agreement signed with Mundipharma for development of a triple combination therapy in asthma GENERIC/ANALOGUE MOLECULE WHOLLY-OWNED AND DEVICE PARTNERING SPECIALIST ASSETS VR315 (US) VR475 (EU) Generic version of Advair® Diskus®(2) for the US, partnered with Hikma Leading wholly-owned specialist drug/device combination using AKITA® JET smart • FDA ANDA file acceptance triggering $10m milestone orf Vectura nebuliser technology delivering nebulised budesonide targeted for severe adult asthma • GDUFA action date 10 May 2017 confirmed • Phase III study recruitment progressing well with results expected mid-2018 VR730 (US) Generic salmeterol inhaled bronchodilator (LABA) for asthma and COPD in DPI device VR647 (US) for the US Wholly-owned specialist drug/device combination using AKITA® JET smart nebuliser • Extended collaboration with Hikma to a third programme technology delivering nebulised budesonide targeted for paediatric asthma • IND filing made and accepted by FDA post period • Phase I study in adults initiated H1 2017 Development initiating on three to five additional programmes, prioritised post merger (1) ALX-0171. (2) Advair Diskus® is a trade mark of GSK. FINANCIAL HIGHLIGHTS Transformational year as a result of Skyepharma merger, Strategic report Financial highlights 1 with strong business performance Vectura at a glance 2 Investment themes 4 Revenue growth Chairman’s statement 6 Our strategy and business model 8 Case study 10 REPORT STRATEGIC KPIs 12 £126.5m Chief Executive’s Q&A 14 Established in-market portfolio 18 9 months to 31/12/16 and proven track record £126.5m Broad late-stage pipeline 20 Year to 31/03/16 and early innovative portfolio £72.0m Uniquely positioned 22 Strong financial discipline 26 Year to 31/03/15 Oral and non-inhaled 28 £58.0m Risk management and internal controls 30 • Headline growth in revenue +75.7% to £126.5m – step change Viability statement 35 in revenue profile driven by the merger with Skyepharma Financial review 36 Corporate responsibility 44 • Recurring(1) revenue now 80.1% of total revenue Governance Corporate governance – 50 EBITDA(2) progression Introduction from the Chairman Board of Directors 52 Executive Leadership Team 54 Corporate governance report 55 £34.1m Nomination Committee report 59 Audit Committee report 60 9 months to 31/12/16 Remuneration Committee report 63 £34.1m Remuneration report 66 Year to 31/03/16 Directors’ report – additional disclosures 85 £23.2m Directors’ responsibilities statement 88 Year to 31/03/15 Financial statements £16.2m Independent auditor’s report 90 Consolidated income statement 98 Consolidated statement 99 Net cash inflow from operating activities of comprehensive income Consolidated balance sheet 100 Consolidated statement 101 of changes in equity £28.2m Consolidated cash flow statement 102 9 months to 31/12/16 Notes to the consolidated 103 financial statements £28.2m Company balance sheet 131 Year to 31/03/16 Company statement of changes in equity 132 £32.9m Notes to the Company 133 Year to 31/03/15 financial statements £8.0m Shareholder information 136 (1) Recurring revenue comprises revenue from royalties, product supply and device sales, and For more information visit: share of sales. Non-recurring revenue comprises other sources of revenue being milestones, www.vectura.com development services and rent received for the Lyon facility during its lease to Aenova. (2) Operating profit before exceptional items and amortisation, adding back charges for share-based payments and depreciation. Report and Accounts for the nine-month period ended 31 December 2016 Vectura Group plc 1 VECTURA AT A GLANCE UNIQUELY POSITIONED FORMULATION AND DEVICE PARTNERING EXPERTS Focusing our core capabilities with a balanced approach to building wholly-owned specialist capability Current sustainable cash flows Future value capture NOVEL PATENTED GENERIC/ANALOGUE WHOLLY-OWNED MOLECULE AND MOLECULE AND SPECIALIST ASSETS DEVICE PARTNERING DEVICE PARTNERING Uniquely integrated inhaled drug delivery platform Formulation Development Devices Vectura has a range of enabling formulations, analytics, process development and pre-commercial scale manufacturing capabilities which are aligned to its range of device technologies. This uniquely integrated inhaled drug delivery platform enables the development of inhalation products and in particular for the treatment of airways diseases. Industry-leading formulation and device technologies Dry powder inhalers (DPIs) GyroHaler® Lever-operated Open-inhale-close Unit-dose Pressurised metered dose inhalers (pMDI) Smart nebuliser technology Dose-indicating MDI actuator AKITA® JET FOX® For more about our device and formulation technology visit: www.vectura.com/technologies 2 Vectura Group plc Report and Accounts for the nine-month period ended 31 December 2016 Our highly skilled employees are committed to achieving our STRATEGIC REPORT STRATEGIC purpose of transforming the lives of airways disease patients c.450 employees Inhalation development activity Chippenham and Cambridge, UK Muttenz, Switzerland Gauting, Germany Corporate office Oral manufacturing site London, UK Lyon, France Uniquely integrated inhaled drug delivery platform Formulation Development Devices Sophisticated Commercially viable Pre-commercial scale analytics processes manufacturing Large and small molecule Formulations and Range of delivery devices Clinical and regulatory drug substance multiple dosage forms development Commercial Early development Phase l Phase ll Phase lll Regulatory approval on-market support Strong IP portfolio • 151 live patent families with over 20 licensees Report and Accounts for the nine-month period ended 31 December 2016 Vectura Group plc 3 INVESTMENT THEMES DELIVERING SUSTAINABLE GROWTH WITH RISK-BALANCED INVESTMENT 1 ESTABLISHED IN-MARKET PORTFOLIO 2 BROAD LATE -STAGE PIPELINE AND AND PROVEN TRACK RECORD EARLY INNOVATIVE PORTFOLIO 20 revenue generating in-market assets, including Balanced pipeline with partnered novel and generic key growth drivers and recurring revenues from programmes and wholly-owned specialist assets. seven recently launched inhaled assets. Broad pipeline includes: 7 valuable late stage novel (1) (1) (2) and generic assets 3 (2) (2) (1) flagship innovative early-stage assets Read more on pages 18 and 19 Read more on pages 20 and 21 3 UNIQUELY POSITIONED 4 STRONG FINANCIAL DISCIPLINE Proven ability with strong partnerships, licensing Clear capital allocation priorities to invest for growth agreements and IP portfolio underpin business evolution and maintain capacity to accelerate strategy. with exposure to key respiratory growth classes. Uniquely integrated inhaled formulation, device and development capabilities. Multiple further business development opportunities Disciplined approach to R&D investment is well in dynamic respiratory market. aligned to strategy. Typical % of total R&D spend 35%–40% 10%–20% 45%–50% Novel patented Generic/analogue Wholly-owned molecule and device molecule and device specialist assets partnering partnering Read more on pages 22 to 25 Read more on pages 26 and 27 (1) Ultibro®, Seebri®, Breezhaler®, AirFluSal® and Forspiro® are registered trademarks of Novartis AG. (2) Anoro® Ellipta®, Relvar®/Breo® Ellipta® and Incruse® Ellipta® are registered trade marks of GSK; photos courtesy of GSK. Formulation technology licence – product not developed by Vectura. 4 Vectura Group plc Report and Accounts for the nine-month period ended 31 December 2016 OUR VALUES PATIENT FOCUS Our patient focus drives what we do and how we do it. We are passionate about improving airways disease patients’ lives every day. CHAIRMAN’S STATEMENT STRONG BUSINESS PERFORMANCE IN A TRANSFORMATIONAL YEAR The Board is delighted with the overall progress made during the period. Bruno Angelici Chairman Summary As previously announced, upon completion of the merger with Skyepharma, Vectura changed its accounting reference date to 31 December from 31 March. This change was made in
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